The Importance of Global Harmonization Efforts
Monday, October 2, 2023
11:15 a.m. - 12:15 a.m.
A complex web of varying global regulatory requirements can serve as barriers to patient access to generic drugs and biosimilars. In this session, panelists will discuss International efforts and engagement in various regulatory arenas: ICH, IPRP, GBHI, and others. FDA will provide an update on the generic drug clusters and parallel scientific advice (PSA) programs. This panel also will touch on how single global development can enable more timely patient access to lower-cost medicines and how regulatory convergence and relying on decisions made by other regulators can reduce costs and streamline processes.
Speakers:
Pradeep Bhadauria
President and Chief Scientific Officer, Cipla LTD
Shobha Reddy Chagam, M.S.
Interim Head Regulatory Affairs North America Generics, Dr. Reddy’s Laboratories Inc.
Sarah Ibrahim, PhD
Associate Director for Stakeholder and Global Engagement, IO, OGD, CDER, FDA
Aaron Josephson, M.S.
Director, Regulatory Policy and Intelligence, Teva Pharmaceuticals
Chaitanya Koduri
Director of International Government and Regulatory Engagement, U.S. Pharmacopeia
Lei Zhang, PhD
Deputy Director, ORA, OGD, CDER, FDA
Panelist:
Nilufer Tampal, PhD
Associate Director for Scientific Quality, OB, OGD, CDER, FDA
